ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters

FDA Premarket Approval P200004

Pre-market Approval Supplement Details

Adult/child 2001(radiotransparent), 2516(radiotranslucent):the conmed padpro radiotransparent and radiotranslucent external multifunction electrodes (mfes) are indicated for use by trained medical professionals in medical facilities or medical transport environments to deliver energy for defibrillation, cardioversion, external pacing, and ecg monitoring applications. The mfe is a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient’s skin. This device is intended for use on defibrillators whose output is classified as low power (up to 360 joule maximum). Aed use: when used in aed mode i. E. For victims of cardiac arrest where there is apparent lack of circulation as indicated by unconsciousness, absence of breathing, and absence of pulse, the electrode is intended for use on patients weighing 25 kg (55 lbs. ) or more. Padpro mfes are not intended to be used for public access pediatric aed defibrillation purposes. Manual use:when used in manual mode, i. E. Under direction of a qualified health care professional, the electrode is intended for use on adult / child patients weighing 10 kg (22 lbs. ) or more. Adult/child model 2502 (sterile):the conmed padpro radiotransparent external multifunction electrodes (mfes) are indicated for use by trained medical professionals in medical facilities or medical transport environments to deliver energy for defibrillation, cardioversion, external pacing, and ecg monitoring applications. The mfe is a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient’s skin. The device is intended for use on defibrillators whose output is classified as low power (up to 360 joule maximum). Aed use:see adult/child 2001, 2516manual use:see adult/child 2001, 2516infant model 2603 and mini-infant model 2602:the conmed padpro radiotranslucent external multifunction electrodes (mfes) are indicated for use by trained medical professionals in medical facilities to deliver energy for defibrillation, cardioversion, external pacing, and ecg monitoring applications. The mfe is a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient’s skin. Not for use in aed mode. Manual use:when used in the manual mode, i. E. Under direction of a qualified health care professional, the electrode is intended for use on infant patients (3-10kg) and mini-infant patients (

DeviceConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantConMed Corporation
Date Received2020-01-31
Decision Date2021-09-26
PMAP200004
SupplementS
Product CodeMKJ 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address ConMed Corporation 525 French Road utica, NY 13502

Supplemental Filings

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Supplement NumberDateSupplement Type
P200004Original Filing

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